MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2004-12-15 for ALLEGIANCE K770 2904 manufactured by Busse Hospital Disposables, Inc..
[375653]
Discovered the tip of the poole suction instrument to be broken after removing suction from patients abdomen. Pt was undergoing abdominal surgery for perforated stomach ulcer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2433012-2004-00001 |
| MDR Report Key | 560244 |
| Report Source | 08 |
| Date Received | 2004-12-15 |
| Date of Report | 2004-12-14 |
| Date of Event | 2004-10-25 |
| Date Mfgr Received | 2004-12-02 |
| Device Manufacturer Date | 2004-05-01 |
| Date Added to Maude | 2004-12-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JEANNIE VIVAR |
| Manufacturer Street | 75 ARKAY DR |
| Manufacturer City | HAUPPAUGE NY 11788 |
| Manufacturer Country | US |
| Manufacturer Postal | 11788 |
| Manufacturer Phone | 6314354711 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLEGIANCE |
| Generic Name | POOLE SUCTION INSTRUMENT |
| Product Code | EBR |
| Date Received | 2004-12-15 |
| Model Number | K770 |
| Catalog Number | 2904 |
| Lot Number | 0420429D |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 549932 |
| Manufacturer | BUSSE HOSPITAL DISPOSABLES, INC. |
| Manufacturer Address | 75 ARKAY DR. HAUPPAUGE NY 11788 US |
| Baseline Brand Name | ALLEGIANCE |
| Baseline Generic Name | POOLE SUCTION INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | K770 |
| Baseline ID | NA |
| Baseline Device Family | POOLE SUCTION INSTRUMENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-12-15 |